Atrial FibrillationNCT06286111
Red Cell Distribution Width as a Predictor for Post Operative Atrial Fibrillation After Open Heart Surgries
An observational study of Atrial Fibrillation and Inflammatory Marker, run by Ain Shams University at 1 site in Egypt.
Trial summary
In this study we investigate the correlation between RDW and POAF, as we use the RDW as a predictor for inflammation for prediction of POAF Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Atrial Fibrillation, Inflammatory Marker, Heart; Surgery, Heart, Functional Disturbance as Result
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Apr 2024to 1 Aug 2024
- How long will I take part?
- 2 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient undergoing open heart surgery with cardiopulmonary bypass used intraoperative, with no history of cardiac tachyarrythemia and not using rythm control drugs with normal cardiac dimensions
Who may be able to join
- Female or Male patient with range of age 35-65 years
- Elective Cardiac surgery
- Cardiopuomonary bypass machine used
- Normal Sinus Rhythm
Who cannot join
- Echo showing left atrial diameter above 4 cm
- Patient on rythm control medications
- Patient undergoing emergency surgery
- History of cardiac Tachyarrhythemia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Red Cell Distribution Width as a Predictor for Post Operative Atrial Fibrillation After Open Heart Surgeries
In this study we investigate the correlation between RDW and POAF, as we use the RDW as a predictor for inflammation for prediction of POAF
Read the detailed description
In this study we investigate the relation between Red Cell Distribution Width and post operative atrial fibrillation after open heart surgery as it's a major complication with high incidence, this complication prolong the in hosoital stay, postulated mechanism of Post Operative Atrial Fibrillation that it's due to inflammation and oxidative stress, after applying specific inclusion and exclusion criteria, recording the preoperative labs including RDW and follow up patients 48 hours post operative in the ICU and recording post operative labs and ECG, and compare the RDW of patients developed POAF and patients who didn't develop POAF
- Conditions
- Atrial Fibrillation, Inflammatory Marker, Heart; Surgery, Heart, Functional Disturbance as Result
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
Red cell distribution width as a predictor for Post-operative Atrial fibrillation after Open Heart Surgeries
The correlation between Red cell distribution width and post operative atrial fibrillation after open heart sutgeries
Measured: 48 hours post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start25 Apr 2024
- Primary completion1 Jun 2024
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06286111
- Sponsor's protocol ID
- ASU MD
- Status last verified
- Feb 2024
- First submitted
- 23 Feb 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Red Cell Distribution Width as a Predictor for Post Operative Atrial Fibrillation After Open Heart Surgeries
- ClinicalTrials.gov ID
- NCT06286111
- Acronym / sponsor ID
- ASU MD
- Conditions
- Atrial Fibrillation, Inflammatory Marker, Heart; Surgery, Heart, Functional Disturbance as Result
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 25 Apr 2024 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 29 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study we investigate the correlation between RDW and POAF, as we use the RDW as a predictor for inflammation for prediction of POAF
Detailed description
In this study we investigate the relation between Red Cell Distribution Width and post operative atrial fibrillation after open heart surgery as it's a major complication with high incidence, this complication prolong the in hosoital stay, postulated mechanism of Post Operative Atrial Fibrillation that it's due to inflammation and oxidative stress, after applying specific inclusion and exclusion criteria, recording the preoperative labs including RDW and follow up patients 48 hours post operative in the ICU and recording post operative labs and ECG, and compare the RDW of patients developed POAF and patients who didn't develop POAF
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Days
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient undergoing open heart surgery with cardiopulmonary bypass used intraoperative, with no history of cardiac tachyarrythemia and not using rythm control drugs with normal cardiac dimensions
Key inclusion criteria (4 listed)
- Female or Male patient with range of age 35-65 years
- Elective Cardiac surgery
- Cardiopuomonary bypass machine used
- Normal Sinus Rhythm
Key exclusion criteria (4 listed)
- Echo showing left atrial diameter above 4 cm
- Patient on rythm control medications
- Patient undergoing emergency surgery
- History of cardiac Tachyarrhythemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Red cell distribution width as a predictor for Post-operative Atrial fibrillation after Open Heart Surgeries
Time frame: 48 hours post operative
The correlation between Red cell distribution width and post operative atrial fibrillation after open heart sutgeries
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Inflammatory Marker, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Red cell distribution width as a predictor for Post-operative Atrial fibrillation after Open Heart Surgeries (time frame: 48 hours post operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.